The recent missteps at Genentech regarding Avastin have deservedly captured all of ophthalmology's attention. One aspect of the issue—off-label drug usage—is receiving interest in other quarters and deserves the attention of all of medicine.
Last month, the Washington Post reported on a draft of an FDA guidance regarding off-label use that would significantly amend the agency's 70-year restriction on marketing of off-label drugs and devices.
The proposal would allow manufacturers to distribute unabridged, reprinted articles from peer-reviewed journals regarding research on off-label usage of drugs and devices. The articles would not be accompanied by any other promotional materials and could not be "written, edited or otherwise 'significantly influenced' by the manufacturers or people with financial ties to them," the Post reports.
If only it were that simple.
With all due respect to the peer-reviewed journals, it's just too hard to tell anymore what is and what isn't "significantly influenced." Whatever that means? Is research support a significant influence? Travel support? You don't have to search very hard to find studies that suggest that "influence" on research results comes from all kinds of sources, financial and otherwise.
Even if this proposal doesn't produce images of foxes guarding hen houses for you, as it does for me, the bigger issue is, where's the need? Manufacturers do have every right to market their products. There is even a First Amendment consideration at play here regarding manufacturers' commercial speech privileges. Thankfully, people who are much smarter and far better informed than I will ultimately have to wrestle with balancing those rights.
But the key element in these decisions is just that—balancing the need to restrict speech against the user's need for and access to the speech you propose to restrict. If you have occasion to look for information from peer-reviewed journals today on off-label usage of a product, do you have a hard time finding it? I don't think so. Is it worth adding yet another voice to the cacophony of medical marketing messages that assail your professional judgment every day? I'm scratching my head bald trying to see the need for that, and it's just not working.
